By Colin Kellaher


Pfizer Inc. on Tuesday said the U.S. Food and Drug Administration granted priority review to its application seeking approval of its RSVpreF respiratory syncytial virus vaccine candidate for administration to pregnant individuals to help protect against the complications of the disease in newborn babies.

The New York drugmaker said the application covers RSVpreF for the prevention of medically attended lower respiratory tract illness and severe medically attended lower respiratory tract illness caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Pfizer said the agency has set a target action date in August for the application.

RSV, a common respiratory virus that people get many times over the course of their lives, can cause serious illness in the very old and young. The virus has caused a surge of cases in emergency rooms and pediatric hospitals this year.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

02-21-23 0730ET